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The Effect Site Concentration of Remifentanil for Conscious Sedation During Awake Nasotracheal Fiberoptic Intubation

This study has been completed.
Sponsor:
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT01052324
First received: January 11, 2010
Last updated: May 12, 2011
Last verified: May 2011
  Purpose

Remifentanil provides analgesia, suppresses airway reflex, has little effect on cognitive function. It can be used for conscious sedation during awake nasotracheal fiberoptic intubation. Target-controlled infusion is more reliable technique for maintaining optimal infusion rate than manual controlled infusion. The aim of this study is to determine the effect site concentration of remifentanil for successful conscious sedation during awake nasotracheal fiberoptic intubation.


Condition Intervention Phase
Cervical Disc Herniation
Cervical Spinal Stenosis
Cervical Spine Damage
Drug: Remifentanil
Phase 4

Study Type: Interventional
Study Design: Primary Purpose: Prevention
Official Title: The Effect Site Concentration of Remifentanil for Conscious Sedation During Awake Nasotracheal Fiberoptic Intubation

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • EC50 of remifentanil for preventing persistent cough and defensive movement using Dixon's up-and-down method [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: March 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Remifentanil
    After topical airway anesthesia with 10 % lidocaine in nostril and oropharyx, 1.5~2.0 mg of IV midazolam is injected. Awake nasotracheal fiberoptic intubation is performed with target-controlled infusion of remifentanil. Initial effect site concentration is 3.0 ng/ml. Smooth intubation is defined as absence of persistent cough with head elevation and defensive movement of extremities. In case of smooth intubation, effect site concentration is decreased by 0.5 ng/ml for the subsequent case. If intubation is not smooth, effect site concentration is increased by 0.5 ng/ml for the subsequent case. EC50 of remifentanil is determined using Dixon's up-and-down method.
  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing cervical spine surgery
  • Age 20-65
  • American Society of Anesthesiologists physical status classification I or II

Exclusion Criteria:

  • Patients' refusal
  • allergy to any drug used
  • unable to cooperate
  • Severe hepatic or renal disease
  • coagulation disorder
  • chronic use of opioids or sedatives
  • increase risk of pulmonary aspiration.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01052324

Locations
Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Yonsei University
Investigators
Principal Investigator: Yuen Hee Shim, MD, PhD Severance Hospital, Yonsei University College of Medicine
  More Information

No publications provided

Responsible Party: Yuen Hee Shim, MD, PhD, Professor of Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Reseach Institute, Yonsei University College of Medicine, Seoul, Republic of Korea
ClinicalTrials.gov Identifier: NCT01052324     History of Changes
Other Study ID Numbers: 4-2009-0609
Study First Received: January 11, 2010
Last Updated: May 12, 2011
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Intervertebral Disc Displacement
Spinal Stenosis
Bone Diseases
Hernia
Musculoskeletal Diseases
Pathological Conditions, Anatomical
Spinal Diseases
Remifentanil
Analgesics
Analgesics, Opioid
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014